To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. Active Pharmaceutical Ingredients is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally.

Topics include:

Safety, efficacy, and environmental/regulatory requirements

Analysis of the recent movement of API manufacturing from the U.S. and Europe to countries such as India and China

The FDA’s intensified foreign inspection program

Multi-use and flexible design facilities

The shift from maintenance scheduling to built-in reliability

This second edition focuses on the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the United States and international regulatory agencies.

Reseña del editor:

Active Pharmaceutical Ingredients is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of Active Pharmaceutical Ingredients (APIs) globally.

This Second Edition brings you up-to-date with the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.

Buchbeschreibung Zustand: New. Brand New Paperback International Edition.We Ship to PO BOX Address also. EXPEDITED shipping option also available for faster delivery.This item may ship fro the US or other locations in India depending on your location and availability. Bestandsnummer des Verkäufers AUSBNEW-36071

Buchbeschreibung Hardcover. Zustand: New. HARDCOVER Book, New Condition, Fast Shipping. Ready in Stock. 2nd Edition. [Please Read Carefully Before Buying], This Is An International Edition. Printed In Black and White. 456 Pages, Book Cover And ISBN No May Be Different From US Edition. Restricted Sales Disclaimer Wordings Not For Sales In USA And Canada May Be Printed On The Cover Of The Book. Standard Shipping 7-14 Business Days. Expedited Shiping 4-8 Business Days. ***WE DO NOT ENTERTAIN BULK ORDERS.*** The Books May Be Ship From Overseas For Inventory Purpose. Bestandsnummer des Verkäufers 439210